There are a vast amount of different types of drugs that come in different forms and are designed to treat a wide range of conditions and illnesses and diseases. One of the more deadly and unfortunately common diseases is cancer. Cancer is a class of diseases in which a group of cells displays uncontrolled growth, which is cell division beyond the normal limits; invasion, which is where cells intrude on and destroy adjacent tissues, and metastasis, which is where cells spread to other locations in the body via lympth or blood. Many cancers can be treated and even some can be cured, depending upon a number of factors, such as the type of cancer, the location and the stage of the cancer. Once diagnosed, cancer is usually treated with a combination of surgery, chemotherapy and radiotherapy. Chemotherapy is the treatment of cancer with drugs that can destroy cancer cells.
One class of chemotherapy drugs is antineoplastics, also known as cytotoxic antibiotics, which are drugs that inhibit and combat development of tumors. Cytotoxic drugs are toxic compounds that are known to have carcinogenic, mutagenic and/or teratogenic potential. With direct contact, these compounds can cause irritation to the skin, eyes, and mucous membranes and ulceration and necrosis of tissue. As a result of the high level of toxicity of these drugs, the exposure of health-care personnel to these drugs should be minimized.
During drug preparation, a variety of manipulations and handling tasks are performed which can result in aerosol generation, spraying, and splattering of the drug. Some of the more common manipulations include but are not limited to: the withdrawal of needles from drug vials, the use of syringes and needles for drug transfer or drug reconstitution, and the expulsion of air from the syringe when measuring the precise volume of a drug. The contamination may be a direct transfer of the drug to the body of the health-care provider or the exterior of the medical product, such as a syringe or IV bag can be contaminated with the drug and then later transferred by direct contact between a person and the contaminated exterior surface.
Pharmaceutical practice calls for the use of aseptic techniques and a sterile environment. Many pharmacies attempt to provide this sterile environment by using a horizontal laminar flow work bench. While this type of equipment provides some benefit, it suffers from a number of shortcomings, including that it can expose the operator and other health-care personnel or others in the same room to aerosols generated during drug preparation procedures. As a result of this concern, a Class 11 laminar flow (vertical) biological safety cabinet (with HEPA filter) that is designed to provide both product and operator protection is needed when dealing with and handling cytotoxic drugs. Syringes and unclipped needles can be disposed of by manually placing these items into leakproof containers.
The disposal of cytotoxic drugs and trace contaminated materials (e.g., gloves, gowns, needles, syringes, vials, etc.) presents a possible source of exposure to pharmacists, nurses, and physicians, as well as to other staff members, including the cleaning and janitorial staff.
The adverse health effects associated with antineoplastic agents (cancer chemotherapy drugs, cytotoxic drugs) in cancer patients and some non-cancer patients treated with these drugs are well-documented. The very nature of antineoplastic agents makes them harmful to healthy constantly dividing cells and tissues, as well as the cancerous cells. For cancer patients with a life-threatening disease, there is a great benefit to treatment with these agents. However, for the healthcare personnel that are exposed to antineoplastic agents as part of their work practice, precautions should be taken to eliminate or reduce exposure as much as possible. There already is a limitation in cytotoxics dissolution in Australia and the United States to 20 dissolutions per pharmacist/nurse, since pharmacists that prepare these drugs or nurses that may prepare and/or administer them are the two occupational groups with the highest potential exposure to antineoplastic agents. In addition, physicians and operating room personnel may also be exposed through the treatment of patients. Hospital staff, such as shipping and receiving personnel, custodial workers, laundry workers, and waste handlers, all have potential exposure to these drugs during the course of their work. The increased use of antineoplastic agents in veterinary oncology also puts these workers at risk for exposure to these drugs.
Since conventional methods for preparing and handling cytotoxin drugs are essentially very manual, labor intensive in nature, the operator performing these tasks is exposed to the hazardous side effects of the cytotoxin drugs. There is therefore a need for an improved, safer method and system for handling cytotoxin drugs particularly in drug preparation and drug transfer environments.